Manufacturing Engineer

About the role

We're looking for a Manufacturing Engineer who can support and enhance production operations by improving quality, reducing defects, and resolving non-conforming material issues within a controlled environment certified to ISO 9001 and regulated by ISO 13485. This role involves supporting the development, qualification, and launch of new products and updates to existing medical devices, ensuring efficient and compliant design transfer into manufacturing.

Responsibilities

• Design manufacturing processes, procedures, and production layouts to optimize productivity, maintainability, and cost for drug-device combination products.
• Optimize drug coating, manufacturing, and packaging processes, improve process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on platform or derivative projects.
• Participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTG) reviews to ensure specifications are well-defined and documented; lead Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
• Manage and support line validation/qualification activities including IQ, OQ, MSA and PQ, including authoring all related documentation and execution of testing protocols.
• Participate in Lean initiatives to stabilize production lines, reduce waste, and improve manufacturing efficiency.
• Calculate production, labor, and material costs and review production schedules to make data-based decisions for improvements.
• Create and review process flow charts, production tooling strategies, production line layouts, production capacity analysis, and EHS project plans.
• Prepare documentation including: testing protocols for product evaluations, work instructions, Control Plans, Manufacturing Processes, job safety analysis sheets, and product and process reports.

Requirements

• Bachelor's degree, or equivalent, in Biomedical, Mechanical, or Industrial Engineering or related field, and 2+ years of experience as a Manufacturing Process Engineer.
• Experience must include: Lean manufacturing methods and procedures, working with ISO 13485/ISO 9001, working in medical device environment, GMP practices, manufacturing quality and product development, project management, knowledge of DFM (Design for Manufacturability), Six Sigma Green Belt and Lean Six Sigma, working with ERP systems, strong problem-solving skills using structured methodologies (5-Why, Fishbone, DMAIC, etc.), solid written and verbal communication skills, ability to manage communication within cross-functional teams and external contractors.
• 5% domestic and/or international travel potential.

Qualifications

• Knowledge of DFM (Design for Manufacturability), Six Sigma Green Belt and Lean Six Sigma.
• Strong problem-solving skills using structured methodologies (5-Why, Fishbone, DMAIC, etc.).
• Solid written and verbal communication skills; able to manage communication within cross functional teams and external contractors.

Skills

• Lean manufacturing methods and procedures.
• Working with ISO 13485/ISO 9001.
• Working in medical device environment, GMP practices.
• Manufacturing quality and product development.
• Project management.
• Knowledge of DFM (Design for Manufacturability).
• Six Sigma Green Belt and Lean Six Sigma.
• Working with ERP systems.
• Strong problem-solving skills using structured methodologies (5-Why, Fishbone, DMAIC, etc.).
• Solid written and verbal communication skills.

Benefits

• Paid time off and paid volunteer time.
• Medical, Dental, Vision and Flexible Spending Account.
• Health Savings Account with Company Funded Contributions.
• 401k Retirement Plan with Company Match.
• Parental Leave and Adoption Services.
• Health and Wellness Programs and Events.
• Awarded 2024 Cigna Healthy Workforce Designation Gold Level.

Pay

Details about pay will be provided during the interview process.

Schedule

Details about the schedule will be provided during the interview process.